Biocompatible fiber textiles for implantation

ABSTRACT

A biocompatible textile and methods for its use and fabrication are disclosed. The textile may be fabricated from electrospun fibers forming windings on a mandrel, in which the windings form openings having a mesh size between adjacent windings. The textile may also be fabricated by the addition of solvent-soluble particles incorporated into the textile while the windings are formed. Such particles may be removed by exposing the textile to a solvent, thereby dissolving them. Disclosed are also replacements for animal organs composed of material including at least one layer of an electrospun fiber textile having a mesh size. Such replacements for animal organs may include biocompatible textiles treated with a surface treatment process.

CLAIM OF PRIORITY

This applications claims benefit of and priority to U.S. ProvisionalApplication No. 61/798,265 entitled “Biocompatible Fiber Textiles forImplantation” filed Mar. 15, 2013, the disclosure of which isincorporated by reference herein in its entirety.

BACKGROUND

In order to repair or replace organs in patients, two independent andoften mutually exclusive parameters must be met. First, any implant musthave structural integrity including a certain amount of rigidity toremain in place once implanted. Second, an implant must be biocompatibleso that it is not rejected by the body or create damaging inflammation.In certain instances the attachment, penetration, and proliferation ofcells is also required for an implant to function as an organ as opposedto a simple prosthesis. No prior implant has been able to embody suchparameters. For example, decellularized organ scaffolds, gels, andpolymer matrices have been implanted, but one or more mechanical orbiological issues have arisen. As such, none of these systems have beenable to provide the appropriate mechanical properties along with thenecessary bio-compatibility.

SUMMARY

In an embodiment, a biocompatible textile may include at least oneelectrospun fiber, composed of at least one polymer, that is disposed ona mandrel, in which the electrospun fiber forms a plurality of windingson the mandrel, each winding of the plurality of windings forming anopening with an adjacent winding, thereby forming a plurality ofopenings between a plurality of adjacent windings. The plurality ofopenings may compose a mesh size.

In an embodiment, a biocompatible textile may include an at least oneelectrospun fiber, composed of at least one polymer, that is disposedlongitudinally along a linear axis of a mandrel, thereby forming aplurality of textile threads, in which the at least one electrospunfiber forms openings between adjacent linearly deposited textile threadsof a mesh size. The plurality of openings may compose a mesh size.

In an embodiment, a method for fabricating a biocompatible textile mayinclude electrospinning a biocompatible polymer into an electrospunfiber, contacting the electrospun fiber with a particulate materialhaving a solubility in a solvent, contacting the electrospun fiber witha receiving surface, thereby forming a polymer network thereon composedof a plurality of electrospun fiber threads and a plurality of spacesbetween adjacent electrospun fiber threads, removing the polymer networkfrom the receiving surface, thereby forming a biocompatible textile, andcontacting the biocompatible textile with the solvent thereby removingthe particulate material. The plurality of openings may compose a meshsize.

In an embodiment, a replacement for an animal organ may include abiocompatible textile composed of at least one electrospun fiber,comprising at least one polymer, disposed on a mandrel, in which theelectrospun fiber forms a plurality of windings on the mandrel, eachwinding of the plurality of windings forming an opening with an adjacentwinding, thereby forming a plurality of openings between a plurality ofadjacent windings, and the plurality of openings comprises a mesh size.Additionally, the mandrel may have a shape of the animal organ or partthereof, and at least one surface of the biocompatible textile compriseswindings of the at least one electrospun fiber treated with a surfacetreatment process.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 illustrates an embodiment of a system for electrospinning apolymer fiber onto a mandrel in accordance with the present disclosure.

FIG. 2A illustrates an embodiment of a system for forming electrospunfibers as windings on a mandrel surface in accordance with the presentdisclosure.

FIG. 2B illustrates an embodiment of a system for forming electrospunfibers as threads along the longitudinal axis of a mandrel in accordancewith the present disclosure.

FIGS. 3A and 3B depict a biocompatible textile formed without theaddition of a water soluble material and a biocompatible textile formedwith the addition of a water soluble material, respectively, inaccordance with the present disclosure.

DETAILED DESCRIPTION

In some embodiments, a textile of embodiments herein may have a luminalstructure composed of multiple windings of one or more biocompatiblefibers. The term “textile” is defined herein as a spun, woven, orotherwise fabricated material comprising fibers. In some embodiments,the fibers may be wound about a mandrel as threads are wound around abobbin. In some embodiments, the fibers may be deposited, in anessentially parallel manner, along a linear dimension of a mandrel orother surface form. In some embodiments, winding the textile may useelectro-spinning techniques.

“Pore size” is thus defined herein as being the diameter of introducedpores, pockets, voids, holes, spaces, etc. introduced in an unmeshedstructure such as block polymer, polymer sheet, or formed polymerscaffold and is specifically distinguished from “mesh size” as disclosedherein.

As used herein, the term “mesh size” is the number of openings in atextile per linear measure. For example, if the textile has 1200openings per linear millimeter, the textile is defined 1200 mesh (e.g.,sufficient to allow a 12 micron red blood cell to pass), which is easilyconvertible between imperial and metric units. A mesh size may bedetermined based on the number of fibers having a specified averagediameter and an average opening size between adjacent fibers along aspecified linear dimension. Thus, a textile composed of 10 μm averagediameter fibers having 10 μm average diameter openings between adjacentfibers may have about 50 total openings along a 1 mm length and maytherefore be defined as a 50 mesh textile.

As used herein, the term “implant” may refer to any structure that maybe introduced for a permanent or semi-permanent period of time into abody. An implant may have the shape and size of a native organ or tissuethat it may serve to replace. Alternatively, an implant may have a shapenot related to a specific bodily organ or tissue. In yet anotherembodiment, an implant may have a shape of an entire bodily organ ortissue, or only a portion thereof. In still another example, an implantmay be shaped like a portion of a bodily organ or tissue, or may simplycomprise a patch of material. The implant may be designed forintroduction into a body of an animal, including a human.

Disclosed herein are compositions and methods for use of textilescomprising spun fibers in biocompatible implants for patients. Incertain embodiments, a polymer fiber is used such as polyurethane and/orpolyethylene terephthalate. In some embodiments, a polymer fiber is spunover a mandrel so as to form a textile roll or tube. In someembodiments, the thickness of the textile roll or tube may be regulatedby changing the number of rotations of the mandrel over time while thetextile roll or tube collects the fiber. In certain other embodiments,the biocompatible textile has a mesh size of about 1 opening per mm toabout 20 openings per mm. Some non-limiting examples of mesh sizes mayinclude about 1 opening per mm, about 2 opening per mm, about 4 openingper mm, about 6 opening per mm, about 8 opening per mm, about 10 openingper mm, about 15 opening per mm, about 20 opening per mm, or rangesbetween any two of these values (including endpoints). In someembodiments, the mesh size of the spun textile may be about 20 openingsper mm to about 500 openings per mm. Some non-limiting examples of meshsizes may include about 20 openings per mm, about 40 openings per mm,about 60 openings per mm, about 80 openings per mm, about 100 openingsper mm, about 200 openings per mm, about 300 openings per mm, about 400openings per mm, about 500 openings per mm, or ranges between any two ofthese values (including endpoints). In other embodiments, the mesh sizemay be about 500 openings per mm to about 1000 openings per mm. Somenon-limiting examples of mesh sizes may include about 500 openings permm, about 600 openings per mm, about 700 openings per mm, about 800openings per mm, about 1000 openings per mm, or ranges between any twoof these values (including endpoints). In some embodiments, the meshsize of the textile may be regulated by changing the speed and directionby which the fiber is deposited onto the mandrel, such as by examplemoving the position and direction in which the thread is spun onto thetextile roll or tube.

The textile having a mesh size may not only provide lightweight andflexible mechanical support, but also in certain embodiments, may allowcells to migrate into and throughout the mesh over time and may improvethe biocompatibility of the implant. In yet other embodiments, thetextile may provide sufficient structural rigidity so as to besurgically secured into an implant site while retaining sufficientflexibility under load stresses such as compression, shear, and torsionso as to allow the patient to physically move about once the implant isin place.

In yet other embodiments, the textile may include an additional surfacetreatment of the polymer fiber which can be used to modulate and enhancecellular attachment to the fibers. In yet other embodiments, the textilemay not cause untreatable inflammation or rejection when implanted in apatient. As such, in certain embodiments, the textile implant may not besubject to rejection or life-threatening inflammation within 1 day, 3days, 5 days, 7 days, 2 weeks, 3 weeks, a month or longer afterimplantation. In some embodiments, the textile implant can be retainedin the patient for at least 1 day, 3 days, 5 days, 7 days, 2 weeks, 3weeks, a month or longer. In certain embodiments, the implant may beretained in the patient for 6 months, a year, a term of years, or thelifetime of the patient. In some of the disclosed embodiments, spacesmay be introduced through directional application of a polymer thread toa mandrel or other surface form during the electrospinning process asdescribed herein. In some other embodiment, spaces may be introducedthrough the addition of particulates to the textile as the polymer fiberis deposited on a mandrel or other surface form during theelectrospinning process as described herein.

While it is contemplated that any method or composition consistent withthe disclosure is embodied, electrospun textiles may have specificadvantages that are useful for implants. For example, when anelectrospun textile is formed from a polymer network deposed on amandrel, the traditional molding processed can be bypassed since thepolymer already exists in the form of a thread before the implant isshaped. As such, a textile based approach to creating biocompatibleimplants allows control of four critical parameters that cannot becontrolled using inherently combined polymerization and moldingprocesses. First, since the polymer is formed as a thread as part of theelectrospinning process, there is no need for setting, curing or othertime-consuming process. Second, the polymer fiber itself can be directedto any orientation for mesh spacing without resorting to chemicalprocesses. The formation of a mesh obviates the need to create pores inan otherwise solid form. Third, the mesh size itself can be adjusted tobe larger or smaller to promote ingrowth and proliferation of cells.Where such meshes are used to provide structural support for growing andmigrating cells, the mesh may also operate as a cellular scaffold inaddition to conferring the other advantages disclosed herein. In certainembodiments, a particle size can similarly be identified by the size ofthe mesh opening such as with the US sieve size, Tyler equivalent, mm,or inches. Fourth, the mesh can be sized to provide structural integritysuch as rebound from deformation, and flexibility under load, and otheradvantageous mechanical properties.

Spinning Textiles

The biocompatible textiles disclosed herein may be manufactured by anymethod. One non-limiting method may include break or open-end spinning,in which slivers are blown by air onto a rotating drum where they attachthemselves to the tail of a formed textile (such as thread, rope oryarn) that is continually being drawn out from the drum. Othernon-limiting methods may include ring spinning and mule spinning. Incertain embodiments, a spinning machine may take a roving, thin it andtwist it, thereby creating a yarn which may be wound onto a bobbin.

In mule spinning, the roving is pulled off a bobbin and fed throughrollers, which feed at several different speeds, thinning the roving ata consistent rate. The thread, rope or yarn is twisted through thespinning of the bobbin as the carriage moves out, and is rolled onto acop as the carriage returns. Mule spinning produces a finer thread thanring spinning. The mule process is an intermittent process, because theframe advances and returns a specific distance, which can produce asofter, less twisted thread favored for fines and for weft. The ringprocess is a continuous process, the yarn being coarser, and having agreater twist thereby being stronger and better suited to be warped.Similar methods have various improvements such as a flyer and bobbin andcap spinning

Electrospinning Textiles

Electrospinning is a method of spinning a polymer fiber or polymernanofiber from a polymer solution by applying of a high voltagepotential between the polymer solution (or polymer injection systemcontaining the polymer solution) and a receiving surface for theelectrospun polymer nanofibers. The voltage potential may includevoltages less than or equal to about 30 kV. The polymer may be ejectedby a polymer injection system at a flow rate of less than or equal toabout 50 ml/h. As the polymer solution travels from the polymerinjection system toward the receiving surface, it may be elongated intosub-micron diameter electrospun polymer nanofibers typically in therange of, about 0.1 μm to about 100 μm. Some non-limiting examples ofelectrospun polymer nanofiber diameters may include about 0.1 μm, about0.2 μm, about 0.5 μm, about 1 μm, about 2 μm, about 5 μm, about 10 μm,about 20 μm, about 50 μm, about 100 μm, or ranges between any two ofthese values (including endpoints).

A polymer injection system may include any system configured to ejectsome amount of a polymer solution into an atmosphere to permit a flow ofthe polymer solution from the injection system to the receiving surface.In some non-limiting examples, the injection system may deliver acontinuous stream of a polymer solution to be formed into a polymernanofiber. In alternative examples, the injection system may beconfigured to deliver intermittent streams of a polymer to be formedinto multiple polymer nanofibers. In one embodiment, the injectionsystem may include a syringe under manual or automated control. Inanother embodiment, the injection system may include multiple syringesunder individual or combined manual or automated control. In someexamples, a multi-syringe injection system may include multiplesyringes, each syringe containing the same polymer solution. Inalternative examples, a multi-syringe injection system may includemultiple syringes, each syringe containing a different polymer solution.

The receiving surface may move with respect to the polymer injectionsystem or the polymer injection system may move with respect to thereceiving surface. In some embodiments, the receiving surface may movewith respect to the polymer injection system under manual control. Inother embodiments, the surface may move with respect to the polymersystem under automated control. In such embodiments, the receivingsurface may be in contact with or mounted upon a support structure thatmay be moved using one or more motors or motion control systems. In somenon-limiting examples, the surface may be a roughly cylindrical surfaceconfigured to rotate about a long axis of the surface. In some othernon-limiting examples, the surface may be a flat surface that rotatesabout an axis approximately coaxial with the polymer fiber ejected bythe polymer injection system. In yet some other non-limiting examples,the surface may be translated in one or more of a vertical direction anda horizontal direction with respect to the polymer nanofiber ejected bythe polymer injection system. It may be further recognized that thereceiving surface of the polymer nanofiber may move in any one directionor combination of directions with respect to the polymer nanofiberejected by the polymer injection system. The pattern of the electrospunpolymer nanofiber deposited on the receiving surface may depend upon theone or more motions of the receiving surface with respect to the polymerinjection system. In one non-limiting example, a roughly cylindricalreceiving surface, having a rotation rate about its long axis that isfaster than a translation rate along a linear axis, may result in aroughly helical deposition of an electrospun polymer fiber formingwindings about the receiving surface. In an alternative example, areceiving surface having a translation rate along a linear axis that isfaster than a rotation rate about a rotational axis, may result in aroughly linear deposition of an electrospun polymer fiber along a linerextent of the receiving surface.

In some embodiments, the receiving surface may be coated with anon-stick material, such as, for example, aluminum foil, a stainlesssteel coating, polytetrafluoroethylene, or combination thereof, beforethe application of the electrospun polymer nanofibers. The receivingsurface, such as a mandrel, may be fabricated from aluminum, stainlesssteel, polytetrafluoroethylene, or combination thereof to provide anon-stick surface on which the electrospun nanofibers may be deposited.In other embodiments, the receiving surface may be coated with asimulated cartilage or other supportive tissue. In some non-limitingexamples, the receiving surface may be composed of a planar surface, acircular surface, an irregular surface, and a roughly cylindricalsurface. One embodiment of a roughly cylindrical surface may be amandrel. A mandrel may take the form of a simple cylinder, or may havemore complex geometries. In some non-limiting examples, the mandrel maytake the form of a hollow bodily tissue or organ. Non-limitingembodiments of such bodily tissues may include a trachea, one or morebronchii, an esophagus, an intestine, a bowel, a ureter, a urethra, ablood vessel, or a nerve sheath (including the epineurium orperineurium).

The polymer solution may be a fluid composed of a solid polymer liquidby the application of heat. Alternatively, the polymer solution cancomprise any polymer or combination of polymers dissolved in a solventor combination of solvents. The concentration range of polymer orpolymers in solvent or solvents may be, without limitation, about 5 wt %to about 50 wt %. Some non-limiting examples of polymer concentration insolution may include about 5 wt %, about 10 wt %, about 15 wt %, about20 wt %, about 25 wt %, about 30 wt %, about 35 wt %, about 40 wt %,about 45 wt %, about 50 wt %, or ranges between any two of these values(including endpoints).

Polymers

In accordance with embodiments herein, a polymer solution used forelectrospinning may typically include synthetic or semi-syntheticpolymers such as, without limitation, a polyethylene terephthalate, apolyester, a polymethylmethacrylate, polyacrylonitrile, a silicone, apolyurethane, a polycarbonate, a polyether ketone ketone, a polyetherether ketone, a polyether imide, a polyamide, a polystyrene, a polyethersulfone, a polysulfone, a polycaprolactone (PCL), a polylactic acid(PLA), a polyglycolic acid (PGA), a polyglycerol sebacic, a polydiolcitrate, a polyhydroxy butyrate, a polyether amide, a polydiaxanone, andcombinations or derivatives thereof. Alternative polymer solutions usedfor electrospinning may include natural polymers such as fibronectin,collagen, gelatin, hyaluronic acid, chitosan, or combinations thereof.It may be understood that electrospinning solutions may also include acombination of synthetic polymers and naturally occurring polymers inany combination or compositional ratio. In some non-limiting examples,the polymer solution may comprise a weight percent ratio of polyethyleneterephthalate to polyurethane of about 10% to about 75%. Non-limitingexamples of such weight percent ratios may include 10%, 25%, 33%, 50%,66%, 75%, or ranges between any two of these values.

The type of polymer in the polymer solution may determine thecharacteristics of the biocompatible textile. Some textiles may becomposed of polymers that are bio-stable and not absorbable orbiodegradable when implanted. Such textiles may remain generallychemically unchanged for the length of time in which they remainimplanted. Alternative textiles may be composed of polymers that may beabsorbed or bio-degraded over time. Such textiles may act as an initialtemplate for the repair or replacement of organs and/or tissues. Theseorgan or tissue templates may degrade in situ once the tissue or organshave been replaced or repaired by natural structures and cells. It maybe further understood, that a biocompatible textile may be composed ofmore than one type of polymer, and that each polymer therein may have aspecific characteristic, such as stability or biodegradability.

Polymer solutions may also include one or more solvents such as acetone,dimethylformamide, dimethylsulfoxide, N-methylpyrrolidone, acetonitrile,hexanes, ether, dioxane, ethyl acetate, pyridine, toluene, xylene,tetrahydrofuran, trifluoroacetic acid, hexafluoroisopropanol, aceticacid, dimethylacetamide, chloroform, dichloromethane, water, alcohols,ionic compounds, or combinations thereof.

The polymer solutions may also include additional materials.Non-limiting examples of such additional materials may include radiationopaque materials, antibiotics, growth factors, vitamins, cytokines,steroids, anti-inflammatory drugs, small molecules, sugars, salts,peptides, proteins, cell factors, DNA, RNA, or any combination thereof

Incorporation of an Anti-Static Bar

During electrospinning, polymer nanofibers are driven toward a receivingsurface by charge separation caused by an applied voltage. The receivingsurface typically is a conductive surface, composed of, for example,aluminum or copper. In some embodiments, the receiving surface iscovered by a thin layer of plastic, ranging, for example, between about0.001 inches (about 0.025 mm) to about 0.1 inches (about 2.5 mm) thick.The force that drives the electrospun polymer solution from the polymerinjection system toward the receiving surface is derived from mobileions within the polymer solution or melt. The polymer solution ejectedby the polymer injection system may have a net positive or negativecharge, depending upon the polarity of the voltage applied to thepolymer injections system and the receiving surface. When theelectrospun polymer nanofiber is deposited on the collector surface toform polymer nanofiber threads, a charge will build up as subsequentnanofiber thread layers are collected. It is believed that as the chargebuilds up on the receiving surface, the nanofibers threads, having asimilar charge, will be repelled. This electrostatic repelling forcemay, thus, lead to irregularly arranged nanofiber threads that will havea lower degree of alignment. In order to reduce the effects of surfacecharge on the receiving surface or its polymer nanofiber threads, theuse of an anti-static device, such as a bar, may be incorporated intothe process to improve nanofibe thread alignment. The anti-static barbombards the receiving surface with positively or negatively chargedions in the form of, for example, a plasma or corona discharge therebyneutralizing the charge on the receiving surface. Therefore, as fiberbuilds up over the receiving surface, successive layers of nanofiberthreads will deposit more uniformly in a side-by-side arrangement(parallel relationship) to increase the alignment. In one embodiment,the position of an anti-static bar is parallel to the surface of thereceiving surface, (for example, a roughly cylindrical mandrel, wheel,device, or plate) and may be, for example, about 0.5 inches (about 13mm) to about 3 inches (about 75 mm) away from the receiving surface.

Experimental results demonstrated that nanofiber thread alignment on thereceiving surface was improved significantly with the addition of ananti-static bar, when compared to samples spun under the same conditionswithout the anti-static bar. For example, the alignment of nanofiberthreads can be about 83% at a low angle orientation when deposited on areceiving surface lacking an anti-static bar. However, a 12% increase infiber alignment—to about 95% —may be observed with the use of ananti-static bar. The use of an anti-static bar may also lead toimprovements in nanofiber thread alignment on the receiving surface forprocesses incorporating polymer injection systems having multiplesyringes. When nanofiber threads are deposited on a receiving surfacelacking an anti-static bar, the nanofiber thread alignment can be low,with about 74% of nanofiber threads deposited in a low angleorientation. With an anti-static bar, under the same spinningconditions, the alignment can become about 92%. It may be appreciatedthat additional embodiments may include processes that incorporate theuse of more than one anti-static bar.

Combined High Velocity and Alternating Ground Alignment

Enhanced alignment of polymer nanofibers produced during electrospinninghas been achieved by various methods including, for example, highvelocity fiber collection (for example, on a receiving surface, such asa mandrel, rotating at a high velocity) and fiber collection betweensequentially placed electrodes on the rotating receiving surface. In onenon-limiting embodiment, the receiving surface may be the rim surface ofa metal spoked wheel. The rim surface of the wheel may be coated with athin insulating layer, such as, for example, a thin layer of polystyreneor polystyrene film. In one non-limiting example, the sequentialelectrodes may be fabricated from conductive tape placed widthwiseacross the insulating material. At least one end of each tape electrodemay contact one or more metal wheel spokes. The conductive tape may becomposed of, for example, carbon or copper and may have a width of about0.1 inches (0.25 cm) to about 2 inches (about 5 cm). In someembodiments, the conductive tape may be spaced in uniform intervalsaround the wheel rim. The intervals between the conductive tape and theinsulating surface may create alternating layers of conductive andnon-conductive surfaces. The metal spokes may be in electrical contactwith the source of the electrospinning voltage providing the voltagedifference between the polymer injection system and the receivingsurface. The combination of a high speed rotational surface and amultiply grounded electrical surface may lead to enhanced fiberalignment.

FIG. 1 illustrates one example of a system for electrospinning a polymernanofiber onto a mandrel to form a polymer network. A polymer injectiondevice 115 may express the polymer solution in drops or in a continuousstream. An electrospun polymer nanofiber 120 may form during the transitof the liquid polymer from the injector 115 to the mandrel 105. Avoltage source may provide a high voltage to the injection device 115with an appropriate ground to the mandrel 105. The mandrel 105 may bemounted on a movable support 110. In one non-limiting embodiment, thehigh voltage ground may be in electrical communication with the support110. In another non-limiting embodiment, the high voltage ground may bein electrical communication with the mandrel 105.

In one non-limiting example, the support 110 may cause the mandrel 105to rotate either in a single direction during the electrospinningprocess, or in alternating directions. In an alternative non-limitingexample, the support 110 may cause the mandrel 105 to translate alongone or more linear axes, x, y and/or z during the electrospinningprocess, or in alternating directions. Such linear motions may permitthe fiber 120 to attach to any portion along the length of the mandrel105 (viz. in the z-direction). Alternatively, liner motions may causethe mandrel 105 to vary in its distance from the tip of the injectiondevice 115 (x- and/or y-directions). It may be understood that thesupport 110 may move the mandrel 105 in a complex motion including bothrotational and translational motions during the electrospinning process.It may further be appreciated that the speed of rotation and/ortranslation of the mandrel 105 during the electrospinning process may beuniform or non-uniform. It may also be appreciated that the mandrel 105on the support 110 may be static and that the injection device 115 mayrotate and/or translate with respect to the static mandrel.

As illustrated in FIG. 1, the electrospun fiber 120 may be wound aboutthe mandrel 105 in a manner similar to that used to wind spun thread ona bobbin. The fiber 120 may be wound in any number of controlledconfigurations about the mandrel 105 based, at least in part, on one ormore factors including the rate of polymer solution injection by theinjection device 115, the voltage potential between the injection deviceand the mandrel, and the rotational and/or translation speed of thesupport 110. The mandrel 105 may have any shape appropriate to the typeof luminal structure intended for manufacture. In one non-limitingexample, the mandrel 105 may have a simple tubular shape, for example,for a vascular support structure. In another non-limiting example, themandrel 105 may be composed of a structure having a single tubular end,and a bifurcated tubular end. It may be apparent that such a shape maybe used to fabricate a polymer network appropriate to replace a tracheaand attendant bronchi. In one non-limiting example, the mandrel 105 maybe composed of metal. In another non-limiting example, the mandrel 105may be coated with a non-stick material, such as, for example, aluminumfoil or polytetrafluoroethylene, to permit easy removal of the polymernetwork from the mandrel. In still another non-limiting embodiment, themandrel 105 may have a collapsible construction, so that the mandrel maybe removed from the polymer network by collapsing the mandrel within thepolymer network, thereby freeing the polymer network from the mandrelsurface. In yet another non-limiting embodiment, the mandrel 105, havinga completed polymer network wrapped around it, may be sprayed with asolvent, such as an alcohol, to loosen the polymer network from themandrel, thereby permitting the polymer network to be removed from themandrel, thereby forming the biocompatible textile. A mandrel 105 havinga more complex shape may be fabricated from a number of reversiblyattachable components. A polymer network fabricated on such a mandrel105 may be removed from the mandrel surface by dissembling the mandrel.

As illustrated in FIG. 1, a rotating mandrel 105 may cause the fiber 120to wrap around the mandrel outer surface forming a plurality of windings125 a,b. The windings 125 a,b may be formed in regular, irregular, or acombination of regular and irregular patterns. In one embodiment, thewindings 125 a,b may form a regular right-handed helix. In oneembodiment, the windings 125 a,b may form a regular left-handed helix.In some embodiments, the windings 125 a,b may form a helix with aboutthe same spacing between adjacent windings. In some embodiments, thewindings 125 a,b may form a helix in which adjacent windings havedifferent spacing between them. In some additional embodiments, thewindings 125 a,b may not form a regular helix, and there may be overlapamong some number of windings. In still another embodiment, the windings125 a,b may be wound around the mandrel 105 in a random manner.

It may be apparent that the polymer network may be composed of a numberof windings 125 a,b. The polymer network may be composed of a singlelayer of windings 125 a,b. In alternative embodiments, the polymernetwork may be composed of a number of layers of windings 125 a,b. Insome embodiments, a number individual fibers 120 may be woundconsecutively around the mandrel 105 to form one or more layers. Inalternative embodiments, each layer may be composed of a number ofwindings 125 a,b of a single fiber 120. In still alternativeembodiments, a number of layers may be composed of a single fiber 120,wound around the mandrel 105 in a succession of layers. It may beappreciated that a void or inter-fiber spacing 130 may be formed betweenadjacent windings, such as between winding 125 a and 125 b. Suchinter-fiber spacings 130 may have a diameter of about 2 microns to about5 microns. Alternatively, such inter-fiber spacings 130 may have adiameter of about 30 micron to about 50 microns. It may be apparent thata textile may include a plurality of inter-fiber spacings 130 having adiameter of about 2 microns to about 50 microns. Non-limiting examplesof such inter-fiber spacings may include about 2 μm, about 4 μm, about 6μm, about 8 μm, about 10 μm, about 20 μm, about 30 μm, about 40 μm,about 50 μm, or ranges between any two of these values (includingendpoints). In additional non-limiting examples, the inter-fiberspacings 130 may have a diameter less than or about equal to about 200microns. The textile may alternatively be characterized by a mesh size.In some non-limiting embodiments, the textile may have a mesh size ofabout 20 inter-fiber spacings 130 per mm to about 500 inter-fiberspacings 130 per mm. Non-limiting examples of such mesh sizes mayinclude about 20 spacings per mm, about 40 spacings per mm, about 60spacings per mm, about 80 spacings per mm, about 100 spacings per mm,about 200 spacings per mm, about 300 spacings per mm, about 400 spacingsper mm, about 500 spacings per mm, or ranges between any two of thesevalues (including endpoints).

An alternative method for fabricating a biocompatible polymer textilemay include surface treatments to further adjust the mesh size of thepolymer network. In one embodiment, a surface treatment may includecontacting particulate material 145 a with one or more of theelectrospun fiber 120, the mandrel 105, or the polymer network disposedon the mandrel. In one non-limiting method, a particulate material 145 bmay be contacted with the electrospun fiber 120 during the spinning step(145 b) before the electrospun nanofiber contacts the mandrel 105. In analternative method, the particulate material 145 c may be contacted witha polymer network of electrospun fibers (145 c) in contact with themandrel 105. The particulate material 145 a may be supplied from aparticulate source 140 placed above or otherwise proximate to theelectrospun fiber 120 or mandrel 105. The particulate source 140 mayinclude any device known in the art including, without limitation, asieve or a shaker. The particulate source 140 may be mechanical innature and may be controlled by an operator directly, a mechanicalcontroller, an electrical controller, or any combination thereof.

The particulate material 145 a may be chosen from any material capableof being dissolved in a solvent that may not otherwise dissolve theelectrospun fibers. In one non-limiting example, the solvent may bewater, and the particulate material 145 a may include water solubleparticulates. Non-limiting embodiments of such water-solubleparticulates may include a water soluble salt, a water soluble sugar, ahydrogel, or combinations thereof. Non-limiting examples of a watersoluble salt may include NaCl, CaCl, CaSO₄, or KCl. Non-limitingexamples of water soluble sugars may include sucrose, glucose, orlactose. The particulate material 145 a may have an average size ofabout 5 μm to about 300 μm. Non-limiting examples of the average size ofsuch particulate material 145 a may include about 5 μm, about 10 μm,about 20 μm, about 40 μm, about 60 μm, about 80 μm, about 100 μm, about150 μm, about 200 μm, about 250 μm, about 300 μm, or ranges between anytwo of these values (including endpoints).

Fabrication methods of multi-layer textiles may include additionalsteps. In some examples, groups of layers may be tack welded togethereither chemically or thermally. Alternatively, layers may be sinteredtogether either through thermal or chemical means.

As disclosed above, a textile may be composed of a number of layers ofwindings 225. Additional features may be added to the textile. In somenon-limiting embodiments, the textile may include one or more curvedsupport structures. Such structures may include rings or U-shapedsupports disposed on the interior of the textile, exterior of thetextile, or between successive layers of fiber windings 125 a,b. Thecurved supports may have any dimensions appropriate for their use. Insome non-limiting examples, the supports may have a width of about 0.2mm to about 3 mm. In some other non-limiting examples, the supports mayhave a thickness of about 1 mm to about 5 mm. Such supports may becomposed of one or more of the following: metals, ceramics, andpolymers. Non-limiting examples of polymers used in such curved supportsmay include: a polyethylene terephthalate, a polyester, apolymethylmethacrylate, polyacrylonitrile, a silicone, a polyurethane, apolycarbonate, a polyether ketone ketone, a polyether ether ketone, apolyether imide, a polyamide, a polystyrene, a polyether sulfone, apolysulfone, a polycaprolactone (PCL), a polylactic acid (PLA), apolyglycolic acid (PGA), a polyglycerol sebacic, a polydiol citrate, apolyhydroxy butyrate, a polyether amide, a polydiaxanone, a chitosan,and combinations or derivatives thereof. Such support may further becomposed of materials that may be non-resorbable or fully degradable.Such supports may be affixed on the mandrel 105 before the fiber 120 iswound about the mandrel surface to form the polymer network.Alternatively, such supports may be affixed on one pre-wound layer offiber 120 of the polymer network before additional layers are wound ontop of it. In yet another embodiment, such supports may be attached tothe outer surface of the polymer network after the winding process iscomplete but before the polymer network is removed from the mandrel 105.Alternatively, after the polymer network has been removed from themandrel 105, thereby forming the biocompatible textile, additionalsupports may be added. Supports may be affixed on the polymer network ortextile by any appropriate means, including, but not limited to, gluing,heat welding, and solvent welding. Additional supports may be formed ofa mesh material over which the fibers 120 may be spun. Such a meshsupport my be rigid, collapsible, and/or expandable.

The polymer network may receive any of number of additional surfacetreatments while still in contact with the receiving surface.Alternatively, once the polymer network has been removed from thereceiving surface, thereby forming the implantable biocompatibletextile, such surface treatments may also be applied. Non-limitingexamples of such surface treatments may include, without limitation,washing in a solvent, drying with a gas stream, sterilizing, sintering,or treating with a plasma discharge. Washing solvents may include waterand alcohol. A drying gas stream may include air, nitrogen, or inert gassuch as argon. A gas stream may include pressurized air or pressurizedionized air. Sterilization techniques may include gamma irradiation.Plasma discharge treatments may be performed in air or in another gassuch as carbon tetrafluoride.

The disclosure above includes a number of embodiments and examples ofpolymer networks and biocompatible textiles fabricated byelectrospinning a polymer to form windings about a mandrel. Suchwindings may be fabricated by rotating the mandrel about a longitudinalaxis and contacting the electrospun polymer nanofiber with the mandrel.During the winding process, the mandrel additionally may be translatedin any of a number of directions (in an x-direction, a y-direction, anda z-direction) with respect to the polymer injection device whilesimultaneously rotating about its longitudinal axis. Alternatively, thepolymer networks or biocompatible textiles may be fabricated bytranslating the mandrel along a longitudinal axis to receive theelectrospun polymer and rotating after a translation step has beenaccomplished. The resulting polymer network structure may not includewindings (that is, a fiber deposited on the mandrel in a circular orcurved path about the mandrel longitudinal axis) but rather may becomposed of overlaid linear threads of fibers deposited on the mandrelsurface along the longitudinal axis of the mandrel.

FIGS. 2A and 2B illustrate some examples of these geometries. Asillustrated in FIG. 2A, mandrel 205 on a support 210 may rotate aboutthe longitudinal axis of the mandrel. The electrospun polymer may becontacted with the mandrel 205 while the mandrel rotates, therebyproducing windings 225 a, 225 b about the longitudinal axis of themandrel with a spacing 230 therebetween. As illustrated in FIG. 2B, themandrel 205 on the support 210 may be linearly translated while thepolymer nanofiber contacts the mandrel surface. As a result, theelectrospun nanofibers may form one or more textile threads 227 a,bhaving a primarily longitudinal orientation along the mandrellongitudinal axis. These textile threads 227 a,b may also becharacterized by an inter-fiber spacing 230. It may be appreciated thatpolymer networks or biocompatible textiles having a variety of fiberand/or winding orientations and spaces may be fabricated based on thedirection and orientation of mandrel motion with respect to the polymerinjector.

It may be understood that in the above disclosure, the use of a mandrelas a polymer receiving surface is not considered limiting. Other typesof surfaces, including planar surfaces, circular surfaces, and irregularsurfaces, may equally be used as receiving surfaces for the polymerelectrospun fibers. Rotational and translations motions of suchalternative receiving surfaces may result in any type of orientation ofpolymer nanofiber threads on or about the receiving surface. Thus, suchpolymer nanofiber threads may form, without limitation, windings, linearalignments, star-shaped alignments, or random alignments.

Biocompatibility

In certain instances, textiles can be manufactured that lack openingsbetween the fibers, and may be considered “meshless” textiles. In such“meshless” textiles, the fibers may be too big to allow openings betweenneighboring fibers. Such fibers in “meshless” textiles may almostentirely overlap each other, thereby creating an effectively continuoustextile surface. Pores, including, without limitation, pockets, spaces,voids, and holes, may be introduced into such “meshless” textiles. Thosehaving skill in the art may recognize that, as one non-limiting example,methods capable of incorporating pores into a polymer block may also beused to introduce pores into “meshless” textiles. An artisan havingaverage skill in the art may recognize that techniques used forintroducing pores into a construct fabricated from a polymer mayinclude, without limitation, solution casting, emulsion casting, polymerblending, and phase transition techniques.

Implants and methods that lead to patient death, or fail to delay,prevent, or mitigate morbidity and mortality, are not within the meaningof the term “biocompatible”. As such, in some embodiments, ineffective,toxic, or deadly compositions are expressly disclaimed herein as they donot meet the necessary requirement of being biocompatible. In someembodiments, non-biocompatible compositions that are specificallydisclaimed are: molded nanocomposites, molded polylactic acid (PLA),molded polyglycolic acid (PGA), molded polycaprolactone (PCL),polycaprolactone/polycarbonate (80:20%) polyhedral oligomericsilsesquioxane; polyhedral oligomer silsesquioxane nanocages; moldedprotein materials, molded collagen; molded fibrin, moldedpolysaccharides molded chitosan, molded glycosaminoglycans (GAGs);molded hyaluronic acid, a set nanocomposite material composed ofpolyhedral oligomeric silsesquioxane (POSS) covalently bonded topoly(carbonate-urea)urethane (PCU) to form a nanocomposite “POSS-PCU”polymer; a POSS-PCU fluid; coagulated POSS-PCU fluid; a POSS-PCU polymerfluid comprising salt crystals; a coagulated POSS-PCU polymer whereinthe salt crystals are dissolved after coagulation to form pores; acoagulated POSS-PCU polymer wherein the salt crystals are a sodium salt,a lithium salt, a potassium salt, carbonate or bicarbonate salt, calciumcarbonate, cobalt(II) carbonate, copper(II) carbonate, lanthanumcarbonate, lead carbonate, lithium carbonate, magnesium carbonate,manganese(II) carbonate, nickel(II) carbonate, potassium carbonate orsodium carbonate; a POSS-PCU polymer wherein the average pore diametermay is about 20-100 microns; a molded polymer wherein the average porediameter is about 20-100 microns, from about 1 nm to about 500 microns,an average diameter of about 10 nm to about 1 micron, about 1 to about10 microns, about 10 to about 100 microns, about 10 to about 50 microns,about 50 to about 100 microns, about 100 to about 200 microns, about 200to about 500 microns, and about 50-100 microns; and a polymer fluidcontaining 50% sodium bicarbonate having an average crystal size ofabout 40 microns.

Surgical Procedures

While the prior disclosed composition of non-textile implants are notwithin the scope of the disclosure, certain other methods includingsurgical methods can be easily adapted for use with the disclosedtextile implants. For example, a subject may be evaluated using one ormore imaging techniques to identify the location and extent of damagedtissue that needs to be removed. In some non-limiting examples, thedisclosed textiles may be seeded on both external and luminal surfaceswith compatible cells that retain at least some ability todifferentiate. In some embodiments, the cells may be autologous cells(e.g., mononuclear cells) that may be isolated from the patient (e.g.,from the patient bone marrow) or a compatible donor. The seeding processmay take place in a bioreactor (e.g., a rotating bioreactor) for a fewdays prior to surgery. Just prior to surgery, additional cells may beadded to the luminal surface of a synthetic tissue composed of abiocompatible textile. In some embodiments, these cells may beepithelial cells, which may be isolated from the patient's airway if thetissue is an airway tissue. Additionally, one or more growth factors maybe added to the synthetic tissue immediately prior to surgery. Thebiocompatible textile incorporating such cells and/or additionalchemical factors may then be transplanted into the patient to replacethe damaged tissue that has been removed. The patient may be monitoredpost-surgically for signs of rejection or of a poorly functional airwaytransplant. It should be appreciated that the addition of cells and/orchemical factors to the biocompatible textile may not be required forevery transplant surgery. Any one or more of these procedures may beuseful alone or in combination to assist in the preparation and/ortransplantation of a synthetic organ or tissue.

In certain embodiments, the biocompatible textiles disclosed herein areused as a tracheal implant. The natural trachea is a cartilaginous andmembranous tube that extends from the lower part of the larynx (at thelevel of the sixth cervical vertebra) to the upper border of the fifththoracic vertebra, where it branches to form the two bronchi. Thetrachea has the shape of a cylinder that is flattened at the back(posterior). The front (anterior) is convex. Without intending to bebound, a typical adult human trachea is at least about 10 cm long, andabout 2-2.5 cm wide. However, it is generally larger in males andsmaller in females. Sometimes, because of disease or trauma, a patientwould benefit from having support or replacement of their airway orportion thereof (e.g., a trachea or portion thereof, a bronchus orportion thereof, or a combination thereof) with a biocompatible textile.

Any airway implant, whether comprising molded implants or textileimplants, may be shaped or formed to represent the region or regions ofthe airway that is being replaced. In some embodiments, the airwayimplant may be roughly cylindrical, thereby forming an air flow conduitafter implantation. Alternatively, the air flow conduit can have thenatural shape of an airway region. For example, in cross-section, theconduit may have a D shape with a convex anterior (e.g., U-shaped) and arelatively straight posterior. The length of the conduit can be designedto effectively match (or be slightly longer than) the length of theairway region being replaced. The air flow conduit can be modeled on theportion of the patient's tissue that is to be replaced by the implant.Accordingly, the dimensions and shape of the implant can be designed tomatch those of the airway region being replaced. It should beappreciated that, depending on the region that is being replaced, theoverall shape of the conduit may be a straight conduit, a Y-shapedbifurcated conduit, or an L-shaped conduit.

As to care of a patient after implantation, certain biological functionsmay be monitored. For example, after implantation of a synthetic ornatural trachea, patient follow-up may include, but is not limited to,endoscopic evaluation (flexible and/or rigid bronchoscopy) of thetransplanted airway every day for the first week, every other day forthe second week, once a month for the first six months thereafter, andevery 6 months for the first 5 years thereafter. Additional patientfollow-up may include an evaluation of the blood count, including whiteblood cell differentials, every second day for the first two weeks,evaluation of the hematopoietic stem cells, immunogenic evaluations (forexample, a blood sample may be taken to study histocompatibility of theimplant by evaluating the antibodies after 3 days, 7 days, 30 days, 3months, 6 months, and 12 months after the transplant,), and computerizedtomography of the neck and chest. Longer term patient follow-up for atransplanted airway can be performed at month 1, month 3, and month 6 ofthe follow-up, and every 6 months thereafter for the first 5 years.Additional oncological follow-up will be life-long and may include thestandard evaluations for such medical condition. In certain embodiments,a biocompatible textile implant may be retained within the patient for 1day, 3 days, 5 days, 7 days, 2 weeks, 3 weeks, or even a month or longerafter implantation. Thus, such textiles can be retained in the patientfor at least these lengths of time commensurate with biocompatibility ofthe implant as disclosed herein. In certain embodiments, a biocompatibletextile implant is retained in a patient for 6 month, a year, a term ofyears, or even as long as the lifetime of the patient.

Although disclosed above are examples of the use of a biocompatibletextile to replace tracheae or laryngeal structures, it may beappreciated that other biological structures, tissues, and organs havinga luminal structure may also be replaced by biocompatible textiledevices. Some non-limiting examples of such luminal structures mayinclude a trachea, a trachea and at least a portion of at least onebronchus, a trachea and at least a portion of a larynx, a larynx, anesophagus, a large intestine, a small intestine, an upper bowel, a lowerbowel, a vascular structure, and portions thereof.

In order to illustrate the various features disclosed above, thefollowing non-limiting examples are provided.

EXAMPLES Example 1 Method of Preparing a Biocompatible Textile

In preparing an exemplary textile, a polymer nanofiber precursorsolution was prepared by dissolving 2-30 wt % polyethylene terephthalate(PET) in a mixture of 1,1,1,3,3,3-hexafluoroisopropanol andtrifluoroacetic acid, and the solution was heated to 60° C. followed bycontinuous stirring to dissolve the PET. The solution was cooled to roomtemperature and the solution placed in a syringe with a blunt tipneedle. The nanofibers were formed by electrospinning using a highvoltage DC power supply set to 1 kV-40 kV positive or negative polarity,a 5-30 cm tip-to-substrate distance, and a 1 μl/hr to about 100 ml/hrflow rate from the syringe. It is possible to use a needle array of upto 1,000's of needles to increase output. An approximately 0.2-3.0 mmthickness of randomly oriented and/or highly-aligned fibers weredeposited onto a receiving surface. Polymer rings were introduced ontothe receiving surface and over the previously spun fibers, and anadditional approximately 0.2-3.0 mm of fiber was added over the surface(including the additional polymer rings) while the form was rotated. Thetextile was placed in a vacuum overnight to ensure removal of residualsolvent (typically less than 10 ppm) and treated using a radio frequencygas plasma for 1 minute to make the fibers more hydrophilic and promotecell attachment.

Example 2 A Biocompatible Textile Fabricated with Soluble ParticulateMaterials

FIGS. 3A and 3B depict two micrographs of biocompatible textiles, oneformed without the addition of a soluble particulate material (FIG. 3A)and one formed with the addition of the soluble particulate material(FIG. 3B). The textiles were formed from a solution of polydioaxonedissolved in hexafluoroisopropanol at a concentration of about 13 wt %.Polymer fibers having a fiber diameter of about 7 μm were electrospunonto a mandrel. FIG. 3A depicts the textile created from thepolydioxanone electrospun alone onto the mandrel and demonstrates aporosity of about 60% (in which porosity may be defined as the fractionof void space in a material). It may be observed that the porosityappears inconsistent across the area depicted in FIG. 3A. A low porosityscaffold may be beneficial in applications where cellular infiltrationis to be avoided or to decrease water permeability. However, a lowporosity scaffold may be a disadvantage or a flaw in applications inwhich cellular infiltration in the scaffold may be desired. It may beappreciated that fibers bonded together as depicted in FIG. 3A may havemechanical properties that differ from those of a mesh scaffold lackingsuch bonding between fibers.

FIG. 3B illustrates a micrograph of a textile formed from the samepolymer solution and solvent, but which further included smallparticulates of NaCl added to the fiber during winding, to form apolymer network including salt. The salt particles had an average sizeof about 50 μm. To remove the salt from the polymer network, the networkwas submerged in three successive changes of water under gentleagitation using a stir bar for about 24 hrs. It may be observed in FIG.3B that the textile mesh is more regular, having an average porosity ofabout 90%. It may be appreciated that the addition of a solubleparticulate material having a known size during the fabrication of thetextile may produce a more homogeneous porosity and may also be a morereproducible process for fabricating the textiles. Reproducibility oftextile properties may improve the utility of the textiles in that thetextiles may be more readily fabricated to meet known specifications. Inaddition to improved reproducibility of the electrospinning process, theaddition of soluble particulates can facilitate the customization of themesh size for specific applications. In one non-limiting example, it maybe necessary to increase the mesh size of the textile to accommodate theseeding or culturing of large clusters of cells presented to the textileas cell spheroids. Such spheroids may contain hundreds of cells and maybe up to several hundred microns in diameter. The larger mesh size mayallow these spheroids to fit into the scaffold without destroying thecell cluster.

While the present invention has been illustrated by the description ofexemplary embodiments thereof, and while the embodiments have beendescribed in certain detail, it is not the intention of the Applicantsto restrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. Therefore, the invention in its broaderaspects is not limited to any of the specific details, representativedevices and methods, and/or illustrative examples shown and described.Accordingly, departures may be made from such details without departingfrom the spirit or scope of the applicant's general inventive concept.

1. A biocompatible textile comprising: at least one electrospun fiber,comprising at least one polymer, disposed on a mandrel, wherein: theelectrospun fiber forms a plurality of windings on the mandrel, eachwinding of the plurality of windings forms an opening with an adjacentwinding, thereby forming a plurality of openings between a plurality ofadjacent windings, and the plurality of openings comprises a mesh size.2. The biocompatible textile of claim 1, wherein the textile isbio-stable.
 3. The biocompatible textile of claim 1, wherein the textileis bio-absorbable or bio-degradable. 4.-5. (canceled)
 6. Thebiocompatible textile of claim 1, wherein the electrospun fiber isselected from one or more of electrospun polyethylene terephthalate,electrospun polyester, electrospun polymethylmethacrylate, electrospunpolyacrylonitrile, electrospun silicone, electrospun polyurethane,electrospun polycarbonate, electrospun polyether ketone ketone,electrospun polyether ether ketone, electrospun polyether imide,electrospun polyamide, electrospun polystyrene, electrospun polyethersulfone, electrospun polysulfone, electrospun polycaprolactone (PCL),electrospun polylactic acid (PLA), electrospun polyglycolic acid (PGA),electrospun polyglycerol sebacic, electrospun polydiol citrate,electrospun polyhydroxy butyrate, electrospun polyether amide,electrospun polydiaxanone, electrospun chitosan, and combinations orderivatives thereof.
 7. The biocompatible textile of claim 1, whereinthe at least one electrospun fiber comprises a plurality of electrospunfibers.
 8. The biocompatible textile of claim 1, wherein the at leastone electrospun fiber comprises an at least one surface-treatedelectrospun fiber.
 9. The biocompatible textile of claim 8, wherein theat least one surface-treated electrospun fiber comprises an at least oneelectrospun fiber comprising a plurality of particles in physicalcommunication with at least a portion of the surface of the electrospunfiber.
 10. The biocompatible textile of claim 9, wherein the pluralityof particles has an average particle size of about 5 μm to about 300 μm.11. (canceled)
 12. The biocompatible textile of claim 9, wherein theplurality of particles comprises a salt, a sugar, a hydrogel material,or any combination thereof.
 13. The biocompatible textile of claim 1,wherein the plurality of windings forms a plurality of circumferentiallayers.
 14. The biocompatible textile of claim 13, wherein at least twoof the plurality of circumferential layers have at least one point ofmutual attachment defined by a tack weld.
 15. The biocompatible textileof claim 13, wherein at least one of the plurality of circumferentiallayers comprises sintered windings of the at least one electrospunfiber.
 16. The biocompatible textile of claim 13, wherein at least oneof the plurality of circumferential layers is in physical contact with aplurality of water soluble particles.
 17. The biocompatible textile ofclaim 13, wherein at least one of the plurality of circumferentiallayers has a mesh size determined by a spacing of about 2 micrometers toabout 50 micrometers between adjacent windings of the at least oneelectrospun fiber. 18.-27. (canceled)
 28. The biocompatible textile ofclaim 1, wherein at least one surface of the biocompatible textilecomprises windings of the at least one electrospun fiber treated with asurface treatment.
 29. The biocompatible textile of claim 1, wherein atleast one surface of the biocompatible textile comprises windings of theat least one electrospun fiber exposed to a jet of pressurized air, ajet of pressurized ionized air, gamma radiation, and a solvent.
 30. Thebiocompatible textile of claim 1, wherein at least one surface of thebiocompatible textile comprises windings of the at least one electrospunfiber exposed to one or more of water and an alcohol.
 31. Thebiocompatible textile of claim 1, wherein the biocompatible textilecomprises windings of the at least one electrospun fiber sonicated inwater, alcohol, or a combination thereof.
 32. The biocompatible textileof claim 1, wherein at least one surface of the biocompatible textilecomprises windings of the at least one electrospun fiber exposed to agas plasma discharge.
 33. The biocompatible textile of claim 32, whereinthe gas is one or more of air and carbon tetrafluoride.
 34. Thebiocompatible textile of claim 1, wherein the mandrel has a cylindricalshape, a biological organ-shape, a shape determined by a computer model,or a shape based on a biological organ of a patient. 35.-37. (canceled)38. The biocompatible textile of claim 1, wherein the mandrel is acollapsible mandrel.
 39. The biocompatible textile of claim 1, whereinthe mandrel has a non-stick surface comprising apolytetrafluoroethylene, a stainless steel, an aluminum, or combinationthereof.
 40. (canceled)
 41. A biocompatible textile comprising: an atleast one electrospun fiber, comprising at least one polymer, disposedlongitudinally along a linear axis of a mandrel, thereby forming aplurality of textile threads, wherein: the at least one electrospunfiber forms openings between adjacent linearly deposited textile threadsof a mesh size; and the plurality of openings comprises a mesh size. 42.A method for fabricating a biocompatible textile comprising:electrospinning a biocompatible polymer into an electrospun fiber;contacting the electrospun fiber with a particulate material having asolubility in a solvent; contacting the electrospun fiber with areceiving surface, thereby forming a polymer network thereon comprisinga plurality of electrospun fiber threads and a plurality of spacesbetween adjacent electrospun fiber threads; removing the polymer networkfrom the receiving surface, thereby forming a biocompatible textile; andcontacting the biocompatible textile with the solvent thereby removingthe particulate material, wherein the plurality of openings comprises amesh size.
 43. The method of claim 42, wherein the solvent is water. 44.The method of claim 42, wherein the particulate material is a salt, asugar, a hydrogel, or any combination thereof. 45.-47. (canceled)